The FDA has granted Orphan Drug Designation for CUDC-907 for the treatment of diffuse large B-cell lymphoma (DLBCL). CUDC-907 is being developed by the Lexington, MA based biotechnology company Curis. It is an oral and dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K). DLBCL is an aggressive and a common subtype of Non-Hodgkin lymphoma, a heterogeneous group of cancer involving lymphocytes. DLBCL is curable in the majority of patients; however, one of the greatest unmet medical needs is prevention and treatment of relapsed or refractory disease. CUDC-907 is currently under clinical trials in patients with relapsed or refractory lymphomas or multiple myeloma as well as in patients with advanced/ relapsed solid tumors.